免疫检查点抑制剂治疗复发或转移性鼻咽癌的疗效与安全性：一项系统评价和荟萃分析。
Efficacy and safety of immune checkpoint inhibitors in the treatment of recurrent or metastatic nasopharyngeal carcinoma: A systematic review and meta-analysis.
作者信息
Yu Zhixin, Hong Shaodong, Yu Hui, Zhang Xuanye, Li Zichun, Chen Ping, Zhou Yixin
机构信息
State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, Guangdong 510000, China.
Department of VIP Region, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong 510000, China.
出版信息
Chin Med J (Engl). 2024 Nov 15;138(5):531-9. doi: 10.1097/CM9.0000000000003371.
BACKGROUND
The combination of immune checkpoint inhibitors and chemotherapy (ICI + Chemo) shows promise in recurrent or metastatic nasopharyngeal carcinoma (RM-NPC), but some patients experience limited benefit and survival predictors remain unclear. Furthermore, ICIs efficacy in subsequent treatments needs further evaluation.
METHODS
A systematic search of PubMed, Embase, the Cochrane Library, and major conference proceedings was conducted to identify studies for meta-analysis. The objective was to compare ICI + Chemo with chemotherapy in first-line treatment and identify efficacy predictors, and to evaluate ICIs alone in subsequent-line treatment for RM-NPC, with a focus on progression-free survival (PFS), objective response rate (ORR), and treatment-related adverse events (AEs).
RESULTS
Fifteen trials involving 1928 patients were included. Three trials compared ICI + Chemo with chemotherapy as a first-line treatment, while 12 trials evaluated ICIs alone in subsequent-line treatment of RM-NPC patients. First-line ICI + Chemo showed superior PFS (hazard ratio [HR] = 0.52, 95% confidence interval [CI], 0.43-0.63; P <0.001) and ORR (risk ratio [RR] = 1.14, 95% CI, 1.05-1.24; P <0.001) compared to chemotherapy, without increased AEs (RR = 1.01, 95% CI, 0.99-1.03; P = 0.481). Neither programmed death-ligand 1 (PD-L1) nor other factors predicted the efficacy of ICI + Chemo vs . chemotherapy. Subsequent-line ICIs alone had a median PFS of 4.12 months (95% CI, 2.93-5.31 months), an ORR of 24% (95% CI, 20-28%), with grade 1-5/grade 3-5 AEs at 79%/14%. However, ICIs alone were associated with significantly shorter PFS (HR = 1.31, 95% CI, 1.01-1.68; P = 0.040) than chemotherapy alone.
CONCLUSIONS
ICI + Chemo confers superior survival benefits compared to chemotherapy in first-line RM-NPC treatment, independent of PD-L1 expression or other factors. However, ICIs alone demonstrate a manageable safety profile but do not surpass chemotherapy in efficacy for subsequent-line treatment.
背景
免疫检查点抑制剂与化疗联合使用（ICI + 化疗）在复发或转移性鼻咽癌（RM-NPC）治疗中显示出前景，但部分患者获益有限，生存预测因素仍不明确。此外，ICI在后续治疗中的疗效有待进一步评估。
方法
系统检索PubMed、Embase、Cochrane图书馆及主要会议论文集，以确定纳入荟萃分析的研究。目的是比较一线治疗中ICI + 化疗与单纯化疗，并确定疗效预测因素，评估RM-NPC后续治疗中单纯ICI的疗效，重点关注无进展生存期（PFS）、客观缓解率（ORR）及治疗相关不良事件（AE）。
结果
纳入15项试验，共1928例患者。3项试验比较了ICI + 化疗与单纯化疗作为一线治疗，12项试验评估了RM-NPC患者后续治疗中单纯ICI的疗效。一线ICI + 化疗与单纯化疗相比，PFS更佳（风险比[HR] = 0.52，95%置信区间[CI]，0.43 - 0.63；P <0.001），ORR更高（风险比[RR] = 1.14，95% CI，1.05 - 1.24；P <0.001），且AE未增加（RR = 1.01，95% CI，0.99 - 1.03；P = 0.481）。程序性死亡配体1（PD-L1）及其他因素均不能预测ICI + 化疗对比单纯化疗的疗效。后续治疗单纯ICI的中位PFS为4.12个月（95% CI，2.93 - 5.31个月），ORR为24%（95% CI，20 - 28%），1 - 5级/3 - 5级AE发生率分别为79%/14%。然而，单纯ICI与单纯化疗相比，PFS显著缩短（HR = 1.31，95% CI，1.01 - 1.68；P = 0.040）。
结论
在一线RM-NPC治疗中，ICI + 化疗较单纯化疗具有更好的生存获益，与PD-L1表达或其他因素无关。然而，单纯ICI安全性可控，但在后续治疗疗效上未超过单纯化疗。
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